Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021970868

FEI Number

3021970868

Entity Name

Microtek Medical LLC

City/State/Country

Eagan, MN, US

Establishment Address

990 Lone Oak Road, Suite 130, Eagan, MN 55121, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microtek Transfer Bottle Collection Bottle Medline Urinal Microtek Ocular Occluder Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad DePuy Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Microtek Medline Light Handle Cover BERMAN AIRWAYS MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE DYNACOR AIRWAYS "Salt Airway S.A.L.T." VARIOUS SIZES DYNACOR AIRWAYS Medline Hard Guedel Airway Intestine Bag Microtek Intestine Bag Medline Silicone Bulb Evacuator for Closed Wound Drainage Medline Evacuator Kit Wound Evac Microtek Medline Wound Drain Kit Remote Control Drape Microtek Lingeman Medline 5-in-1 connector Medline Connecting Tubing MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY DYNACOR SUCTION CONNECTING TUBING Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Safety frames / lens Microtek Drape Armour

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
FNP	Urinal	General Hospital	Class 1	880.6730	1991-12-30
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2024-10-31
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-10-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-02-01
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2018-03-22
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-02-01
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2024-10-30
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2014-10-16
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2016-01-13
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2024-10-30
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2005-02-01
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2015-01-13

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021970868. Last updated year: 2026. Please use registration number 3021970868 when referencing this establishment in official correspondence.